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儿童β-内酰胺类药物过敏与药物激发试验:一项系统评价与荟萃分析

Beta-lactam allergy and drug challenge test in children: a systematic review and meta-analysis.

作者信息

Kuniyoshi Yasutaka, Tsujimoto Yasushi, Banno Masahiro, Taito Shunsuke, Ariie Takashi, Kubota Takafumi, Takahashi Natsuki, Tokutake Haruka

机构信息

Department of Pediatrics, Tsugaruhoken Medical COOP Kensei Hospital, 2-2-2 Ougi-machi, Hirosaki, Aomori, 036-8511, Japan.

Scientific Research WorkS Peer Support Group (SRWS-PSG), Osaka, Japan.

出版信息

Pediatr Res. 2023 Jan;93(1):22-30. doi: 10.1038/s41390-022-02076-x. Epub 2022 Apr 21.

Abstract

BACKGROUND

Most cases of beta-lactam allergy in children are likely to be mislabeled. This study aimed to assess the prevalence of true positives, as determined by drug challenge tests, and the rate of false negatives in children with suspected allergies and confirm the safety of the drug challenge test.

METHODS

We conducted a systematic review and meta-analysis according to established procedures. Study participants were children with suspected beta-lactam allergy who underwent a drug challenge. PubMed MEDLINE, Dialog EMBASE, Cochrane Central Register of Controlled Trials, World Health Organization International Clinical Trials Registry Platform, and clinicaltrials.gov were searched from inception until March 5, 2021.

RESULTS

The pooled prevalence of (a) positive results in the first challenge was 0.049 (95% CI, 0.041-0.057; I = 71%) from 78 studies; (b) serious adverse events was 0.00 (95% CI, 0.00-0.00; I = 0.0%) from 62 studies; and (c) positive results in the second challenge after the first negative result was 0.028 (95% CI, 0.016-0.043; I = 38%) from 18 studies.

CONCLUSIONS

The prevalence of children with suspected beta-lactam allergy with true-positive results and false-negative results from the drug challenge test was very low. Serious adverse events resulting from drug challenge tests were also very rare.

IMPACT

Most children with suspected beta-lactam allergy were likely to be mislabeled. Serious adverse events caused by the drug challenge test were rare. Few false-negative results were obtained from the drug challenge test.

摘要

背景

儿童中大多数β-内酰胺类药物过敏病例可能被错误标记。本研究旨在评估通过药物激发试验确定的真阳性患病率以及疑似过敏儿童中的假阴性率,并确认药物激发试验的安全性。

方法

我们按照既定程序进行了系统评价和荟萃分析。研究参与者为接受药物激发试验的疑似β-内酰胺类药物过敏儿童。检索了PubMed MEDLINE、Dialog EMBASE、Cochrane对照试验中心注册库、世界卫生组织国际临床试验注册平台和clinicaltrials.gov,检索时间从建库至2021年3月5日。

结果

(a)78项研究中首次激发试验阳性结果的合并患病率为0.049(95%CI,0.041 - 0.057;I² = 71%);(b)62项研究中严重不良事件的合并患病率为0.00(95%CI,0.00 - 0.00;I² = 0.0%);(c)18项研究中首次阴性结果后第二次激发试验阳性结果的合并患病率为0.028(95%CI,0.016 - 0.043;I² = 38%)。

结论

药物激发试验中疑似β-内酰胺类药物过敏儿童的真阳性和假阴性结果患病率非常低。药物激发试验导致的严重不良事件也非常罕见。

影响

大多数疑似β-内酰胺类药物过敏的儿童可能被错误标记。药物激发试验引起的严重不良事件很少见。药物激发试验获得的假阴性结果很少。

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